R&D Engineer II (Medtech)

TL;DR

R&D Engineer II (Medtech): Maintaining the design integrity of commercially available medical devices with an accent on root cause investigations, complaints analysis, and design verification. Focus on solving complex technical problems in structural heart disease treatment and implementing corrective measures to ensure product reliability.

Location: Santa Ana, California, USA. Must work onsite a minimum of 4 days per week

Salary: $88,800 - $133,200 USD

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life for millions of patients.

What you will do

• Perform root cause investigations, complaints analysis, and implement corrective and preventive measures for released products.
• Develop design concepts, prototypes, and test methodologies for material, component, and device level testing.
• Conduct design verification and validation testing according to regulatory and approved protocols.
• Maintain product design integrity of commercial products using sound engineering principles and Design Control requirements.
• Collaborate with Manufacturing and Quality Engineers to investigate reliability issues and implement solutions.
• Review and approve change orders, design qualifications, and verification documentation for post-market products.

Requirements

• Bachelor's degree in Engineering or a related technical field.
• Minimum of 2 years of professional experience (or an advanced degree).
• Unrestricted U.S. work authorization required (Sponsorship is not available for this level).
• High proficiency in medical device design and manufacturing principles.
• Ability to work onsite in Santa Ana, CA at least 4 days per week.

Nice to have

• Experience in Released Product Engineering.
• Experience with Implant Design, Tissue processing, or Nitinol material and stent processing.
• Experience with textile and suture development and testing.
• Background in design and process qualification.

Culture & Benefits

• Comprehensive health, dental, and vision insurance, including HSA and Healthcare FSA.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and an Employee Stock Purchase Plan.
• Short-term incentive plan (hirify.global Incentive Plan - MIP).
• Tuition assistance/reimbursement and the Simple Steps global well-being program.
• Collaborative, high-performing environment focused on patient-first innovation.